PROLYTE® - COFEPRIS Registration 348E2022 SSA
Access comprehensive regulatory information for PROLYTE® (PROLYTE®) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 348E2022 SSA and manufactured by DICIPA, S.A. DE C.V.. The device was registered on May 03, 2022.
This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
PROLYTE® ES UN ANALIZADOR AUTOMATIZADOCONTROLADOPORUNMICROPROCESADORQUEUTILIZATECNOLOGÍA DE ELECTRODOS SELECTIVOS DE IONES,DISEÑADOPARAQUELOSPROFESIONALESDELASALUDLOUTILICENENELLABORATORIOCLÍNICOPARAEVALUARLOSNIVELESDESODIO,POTASIO,CLORUROYLITIOENSANGREENTERA,PLASMAYSUERODELOSPACIENTES.ELSODIO,POTASIOYCLORUROTAMBIÉNSEEVALÚANENLAORINA.AGENTEDEDIAGNÓSTICOPARAUSOINVITRO,PARAUSOEXCLUSIVO DE LABORATORIOS CLÍNICOS O DE GABINETES.
PROLYTE® IS AN AUTOMATED, MICROPROCESSOR-CONTROLLED ANALYZER USING ION-SELECTIVE ELECTRODE TECHNOLOGY, DESIGNED FOR USE BY HEALTHCARE PROFESSIONALS IN THE CLINICAL LABORATORY TO ASSESS THE LEVELS OF SODIUM, POTASSIUM, CHLORIDE, AND LITHIUM IN PATIENTS' WHOLE BLOOD, PLASMA, AND SERUM. SODIUM, POTASSIUM and CHLORIDE are also evaluated in urine. DIAGNOSTIC AGENT FOR USE IN THE HOSPITAL, FOR THE EXCLUSIVE USE OF CLINICAL LABORATORIES OR CLINICS.